Leader in
Pharmacovigilance Solutions

We are here, every step of the way with our turn key Pharmacovigilance Solutions

One Step Ahead

Why We Are The Best

4C is run and managed by medical doctors who have evolved from the Industry of Clinical Research and Pharmacovigilance Solutions or Pharmacovigilance (PV) Outsourcing. With handpicked best talents from the industry  and trained them on robust 4C curriculum to deliver best in class service and experience to our Small, Medium and Large pharma clients. 4C excels in providing end to end effective monitoring of safety and efficacy for Drugs, Devices, Biologics & Nutraceutical. 

A Holistic approach to our customers needs

- Medical Information Call Centre
- Follow up with reporters
- Literature Search
- In-House Argus
- Automated MICC Software

- Case Processing
- Quality Check
- Medical Review
- Paper, SRP, ESG Submissions
- PI/IRB Submissions

- Periodic Reports
- QPPV Support
- Signal Management
- Regulatory Intelligence
- Risk Management

- Data Quality Management
- PMS and PASS
- Reconciliation
- Metrics Management
- PV Audit Preparation

360
Pharmacovigilance Solutions

Explore What We Are Doing Better

ONGOING SUPPORT

Medical Monitoring

Risk-Benefit Assessment

Pharmacovigilance Solutions

ADHOC SUPPORT

Regulatory Authority Requests, Audit/ Inspection

Health Care Analytics

VETERINARY
Pharmaccovigilance Solutions

4C is equipped to support adverse events report of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary guidelines as well as HL7 complaint system required by the FDA’s Center for Veterinary Medicines and as defined by the VICH.

Veterinary
Pharmacovigilance Solutions

Veterinary pharmacovigilance is defined in Article 73 of Directive 2001/82/EC covers not only the safety aspects in animals and in humans related to veterinary medicinal products, but also other aspects of post-authorization surveillance. The system also considers any available information arising from the use of veterinary medicinal products, such as:

  • Lack of expected efficacy of veterinary medicinal products
  • Adverse reaction reports related to off-label use
  • Reported violations of approved residue limits, possibly leading to investigations of the validity of the withdrawal period
  • Potential environmental Problems

Case Processing

Literature Search

Three Day Field Alert Reports

Serious Adverse Reaction Reports in Animals

Reports of Adverse Reactions in Humans

Adverse Drug Events Reports and PSURs

Report Submission

Reporting

Medical Information Call Center

Pharmacovigilance Systems have been moving towards better environment and better reporting platforms. This change was initiated by EMA which is preparing its systems to accept E2B(R3) reports from 22-Nov-2017.

We believe in delivering only but the best Pharmacovigilance Solutions